Billing chart: Blue Cross highlights medical, benefit policy changes

A9291

Basic benefit and medical policy

Digital health technologies for ADHD

The use of EndeavorRx^® is considered experimental for all indications including attention-deficit/hyperactivity disorder, effective May 1, 2024.

81382, 81479,** 81554, 82397, 82784,
83520, 84999,** 86021, 86140, 86255,
87045, 87046, 87075, 87102, 87177,
87209, 87328, 87329, 87336, 87798,
88346, 88350

Basic benefit and medical policy

Miscellaneous, genetic, and molecular diagnostic tests

Diagnostic and prognostic genetic testing of an affected (symptomatic) individual’s germline to benefit the individual (excluding reproductive testing) or of an asymptomatic individual to determine future risk of disease is considered experimental for the following:

• Prometheus^® Celiac PLUS
• Prometheus^® Crohn’s Prognostic
• DNA Methylation Pathway Profile
• GI Effects^® (Stool)
• Prometheus^® IBD sgi Diagnostic^®
• Know Error™
• Envisia™ Genomic Classifier (Veracyte™)

All miscellaneous laboratory diagnostic tests listed in the policy are considered experimental. There is insufficient evidence to determine that the technology results in an improvement in net health outcomes.

This policy has been updated, effective May 1, 2024.

Note: If a separate policy exists, then the criteria in that policy supersedes the guidelines herein.

Payment policy:

Established codes may be considered experimental for the purpose of this policy.

81408, 81432, 81433, 81479**

Basic benefit and medical policy

Gene variants associated with breast cancer in individuals at high risk

BARD1, CHEK2, NFI, PTEN, RAD51C, RAD51D, STK11 and TP53 variants for breast cancer risk assessment in adults is considered established. It may be considered a useful diagnostic option when indicated.

Inclusionary and exclusionary criteria have been updated, effective May 1, 2024. 

Note: For BRCA1/2 and PALB2 testing please refer to policy “Germline Genetic Testing for BRCA1, BRCA2 and PALB2 for Hereditary Breast Ovarian Cancer Syndrome and Other High-Risk Cancers.”

Criteria for genetic risk evaluation

The National Comprehensive Cancer Network, or NCCN, provides criteria for genetic risk evaluation for individuals with no history of breast cancer and for those with a breast cancer. Updated versions of the criteria are available on the NCCN website, located here: https://www.nccn.org/professionals/physician_gls/default.aspx.

Note:

• For the purpose of this policy, close blood relatives include first, second- and third-degree relatives who are blood relatives on the same side of the family (maternal or paternal), such as:
• First-degree relatives are parents, siblings and children.
• Second-degree relatives are grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings.
• Third-degree relatives are great-grandparents, great-aunts, great-uncles, great-grandchildren and first cousins.
• For the purpose of this policy, high-risk and very-high-risk prostate cancer groups are defined as follows:
• High-risk group: No very-high-risk features and are T3a (American Joint Committee on Cancer staging T3a=tumor has extended outside of the prostate but has not spread to the seminal vesicles); or grade group 4 or 5; or prostate specific antigen of 20 ng/ml or greater.
• Very high-risk group: T3b-T4 (tumor invades seminal vesicle(s); or tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall); or Primary Gleason Pattern 5; or 2 or 3 high-risk features; or two or three greater than 4 cores with grade group 4 or 5.

Inclusions:

Testing is clinically indicated in the following scenarios:

• Individuals with any close blood relative with a known ATM, CDH1, BARD1, CHEK2, NFI, PTEN, RAD51C, RAD51D, STK11 or TP53 pathogenic or likely pathogenic variant.
• Individuals meeting the criteria below but with previous limited testing (e.g., single gene or absent deletion duplication analysis) who are interested in multi-gene testing.
• A pathogenic or likely pathogenic variant identified on tumor genomic testing that has clinical implications if also identified in the germline.
• To aid in surgical decision-making.
• Genetic testing for ATM, CDH1, BARD1, CHEK2, NFI, PTEN, RAD51C, RAD51D, STK11 or TP53 variants in cancer-affected individuals may be considered appropriate under any of the following circumstances:

• Personal history of breast cancer, including invasive and ductal carcinoma in situ breast cancers, and any of the following:
• Diagnosed age ≤50 years
• Diagnosed at any age with any of the following: 
• Pathology/histology
• Triple-negative breast cancer
• Multiple primary breast cancers (synchronous or metachronous)
• Lobular breast cancer with personal or family history of diffuse gastric cancer
• Male breast cancer
• Ashkenazi Jewish ancestry
• Family history of any of the following:
• ≥1 close blood relative with any:
• Breast cancer diagnosed ≤50 years
• Male breast cancer any age
• Ovarian cancer any age
• Prostate cancer with metastatic, or high- or very high-risk group any age
• Pancreatic cancer any age

• ≥3 diagnoses of breast cancer or prostate cancer (any grade) on the same side of the family including the patient with breast cancer.

• Family history of breast cancer only (any of the following):
• Individuals affected with breast cancer (not meeting the criteria above) or unaffected individual with breast cancer with a first- or second-degree blood relative meeting any of the criteria listed above (except unaffected individuals whose relatives meet criteria only for systemic therapy decision-making). 

• Individuals affected or unaffected with breast cancer who otherwise don’t meet the criteria above but have a probability >5% of a BRCA1/2 pathogenic or likely pathogenetic variant based on prior probability testing models (e.g., Tyrer-Cuzick, BRCAPro, CanRisk).

In addition to the above gene variant testing for individuals with breast cancer, the following specific gene variants are established with the below criteria.

• Genetic testing for ATM, RAD51C and RAD51D variants in individuals may be considered appropriate under any of the following circumstances:
• History of epithelial ovarian cancer and any of the following:
• Personal history of epithelial ovarian cancer (including fallopian tube cancer or peritoneal cancer) at any age.
• Family history of epithelial ovarian cancer only.
• An individual unaffected with ovarian cancer with a first- or second-degree blood relative with epithelial ovarian cancer (including fallopian tube cancer or peritoneal cancer) at any age.
• An individual unaffected with ovarian cancer who otherwise doesn’t meet the criteria above but has a probability >5% of a BRCA1/2 P/LP variant based on prior probability models (e.g., Tyrer-Cuzick, BRCAPro, CanRisk).
• Genetic testing for ATM, STK11 and TP53 variants in individuals diagnosed with exocrine pancreatic cancer and one of the following;
• All individuals diagnosed with exocrine pancreatic cancer.
• First-degree relatives of individuals diagnosed with exocrine pancreatic cancer.
• Genetic testing for ATM or CHEK2 variants in individuals may be considered appropriate under any of the following circumstances:
• Personal history of prostate cancer and any of the following:
• By tumor characteristics (any age)

• Metastatic 
• Histology – high- or very-high-risk group

• By family history and ancestry
•  ≥1 close blood relative with any:
  

  – Breast cancer at age ≤50 years 
  – Triple-negative breast cancer at any age 
  – Male breast cancer at any age
  – Ovarian cancer at any age
  – Pancreatic cancer at any age
  – Metastatic, high-, or very-high-risk group at any age.

• ≥3 close blood relatives with prostate cancer (any grade) or breast cancer on the same side of the family including the patient with prostate cancer
• Ashkenazi Jewish ancestry

• Family history of prostate cancer only:
• An affected (not meeting testing criteria listed above) or unaffected individual with a first-degree blood relative meeting any of the criteria listed (except unaffected individuals whose relatives meet criteria only for systemic therapy decision-making).

Exclusions:

• Patients not meeting any of the above criteria
• Genetic testing for ATM, CDH1, BARD1, CHEK2, NFI, PTEN, RAD51C, RAD51D, STK11 or TP53 variants in minors

95905, G0255

Basic benefit and medical policy

Automated point-of-care nerve conduction tests

The effectiveness and clinical utility of nerve conduction testing devices that automate the placement, recording and interpretation of test results haven’t been established. Therefore, while they may be safe, the use of automated nerve conduction studies is considered experimental. This policy was updated effective May 1, 2024.

37242, 37244

Basic benefit and medical policy

Prostatic arterial embolization for BPH

Prostatic arterial embolization, or PAE, for benign prostatic hyperplasia, or BPH, is established, effective May 1, 2024. It may be considered a useful therapeutic option when criteria are met. Prostatic artery embolization for treatment of hematuria of prostatic origin is established. It may be considered a useful option when criteria are met.

Inclusions: 
PAE for BPH may be considered established when all the following are met:

• Selection is done by a multidisciplinary team involving both a urologist and an interventional radiologist
• Gland size 50 grams or greater
• Preserved bladder function

And one of the following is met:

• Moderate to severe lower urinary tract symptoms, or LUTS, by International Prostate Symptoms Score, or IPSS,^a refractory to medical management^b 
• Moderate to severe LUTS in individuals who are poor surgical candidates (e.g., advanced age, multiple comorbidities, or inability to stop anticoagulation or antiplatelet therapy)
• Acute or chronic urinary retention, requiring urinary catheter use.

PAE for hematuria of prostatic origin may be considered medically necessary when one of the following is met:

• 5-alpha reductase inhibitors^c, or ARI, therapy has failed
• Acute bleeding that is uncontrolled with conservative measures
• Recurrent bleeding that is uncontrolled with conservative measures

^aIPSS is a reproducible, validated index designed to determine disease severity and response to therapy. Scores range from 0 to 35. Mild (≤7), moderate (8-19), or severe (20-35).

^bDocumented failure (no clinical improvement after three months of therapy), inability to tolerate, or undesirable side effects or pharmacologic intervention for BPH

^cExamples consist of finasteride and dutasteride (brand names: Proscar, Propecia, Avodart, and Jalyn)

Note: Procedure should only be done by an interventional radiologist with specific training and expertise in prostatic artery embolization.

Exclusions:

• Bladder cancer
• Catheter dependence over 12 months
• Detrusor or bladder dysfunction
• Gland size < 50 grams
• High-grade prostate cancer/Gleason Score >7
• Large bladder diverticula
• Neurogenic lower urinary tract dysfunction or neurogenic bladder
• Repeat PAE for BPH treatment
• Uncorrectable coagulopathy

Note: Procedure code *37242, previously not payable for BPH, will have the diagnostic exclusions removed, effective May 1, 2024.

81349, 81415, 81416, 81417, 81425, 81426, 81427, 0094U, 0425U, 0426U

Experimental
0212U, 0213U, 0214U, 0215U, 0335U, 0336U

Basic benefit and medical policy

Genetic testing – whole exome and whole genome sequencing for diagnosis of genetic disorders

The safety and effectiveness of whole exome sequencing, or WES, may be considered established. It may be considered a useful diagnostic tool when indicated.

The safety and effectiveness of rapid whole exome sequencing, rapid or ultrarapid whole genome sequencing, with trio testing when possible, may be considered established. It may be considered a useful diagnostic tool when indicated. 

WES is considered experimental for the diagnosis of genetic disorders in all other clinical situations.

Repeat whole exome sequencing for the diagnosis of genetic disorders, including re-analysis of previous test results, is considered experimental.

Whole genome sequencing, or WGS, is considered experimental for the diagnosis of genetic disorders in all other clinical situations.

WES and WGS are considered experimental for screening for genetic disorders.

The Medical Policy Statement and inclusionary and exclusionary criteria have been updated, effective May 1, 2024. The guidelines are listed below.

Inclusions:

Whole exome sequencing, or WES, with trio testing (testing child and both parents) when possible, may be considered established for the evaluation of unexplained congenital or neurodevelopmental disorders in children when all of the following criteria are met:

• The patient has been evaluated by a specialist with specific expertise in clinical genetics and counseled about the potential risks of genetic testing.

• There is a potential for a change in management and clinical outcome for the individual being tested.

• A genetic etiology is the most likely explanation for the phenotype despite previous genetic testing, such as chromosomal microarray or targeted single gene testing, or when previous genetic testing has failed to yield a diagnosis and the affected individual is faced with invasive procedures or testing as the next diagnostic step, such as muscle biopsy.

Rapid whole exome sequencing or rapid whole genome sequencing or ultra-rapid whole genome sequencing, with trio testing (testing child and both parents) when possible, for the evaluation of critically ill infants and children in neonatal or pediatric intensive care with a suspected genetic disorder of unknown etiology when at least one of the following criteria is met:

• Multiple congenital anomalies

• An abnormal laboratory test or clinical features suggests a genetic disease or complex metabolic phenotype

• An abnormal response to standard therapy for a major underlying condition

Exclusions:

Rapid whole exome sequencing or rapid whole genome sequencing or ultra-rapid whole genome sequencing, with trio testing when possible, isn’t established for the evaluation of critically ill infants and children in neonatal or pediatric intensive care with a suspected genetic disorder of unknown etiology in cases where one of the following apply as the reason for admission to intensive care:

• An infection with normal response to therapy
• Isolated prematurity
• Isolated unconjugated hyperbilirubinemia
• Hypoxic ischemic encephalopathy
• Confirmed genetic diagnosis explains illness
• Isolated transient neonatal tachypnea
• Nonviable neonates
• WES and WGS for the diagnosis or screening of genetic disorders in all other situations
• Repeat whole exome sequencing for the diagnosis of genetic disorders, including re-analysis of previous test results

61736, 61737

Basic benefit and medical policy

Laser interstitial therapy for neurological conditions

Laser interstitial thermal therapy is considered established for the treatment of epilepsy, radiation necrosis, recurrent glioblastoma and relapsed brain metastases, in individuals who meet the selection criteria.

Laser interstitial thermal therapy is considered experimental for all other neurological conditions. 

The Medical Policy Statement and inclusionary and exclusionary criteria have been updated, effective May 1, 2024. Guidelines are listed below.

Inclusions:

Laser interstitial thermal therapy, or LITT, is considered established in the treatment of refractory epilepsy when all of the following criteria are met:

• There is documentation of disabling seizures** despite use of two or more antiepileptic drug regimens*** (i.e., medication-refractory epilepsy).
• There are well-defined epileptogenic foci accessible by LITT.
• A multidisciplinary team of physicians that includes at least two specialties (e.g., neurology, neurosurgery), after considering all possible treatments, agrees that LITT is the best treatment option for the patient.

**Disabling seizures can be defined as seizures that result in impairment or a loss of functional status.

***Antiepileptic drug regimens are defined as two tolerated and appropriately chosen and used antiepileptic drug schedules (as monotherapies or in combination) to achieve sustained seizure freedom.

• Laser interstitial thermal therapy, or LITT, is considered established for individuals who are poor candidates for craniotomy or resection when one of the following criteria are met:
• Relapsed brain metastases
• Radiation necrosis
• Recurrent glioblastoma

And

• The treatment plan to use LITT has been agreed upon by a multidisciplinary team of physicians to include at least two specialists (e.g., neurosurgery, oncology) and after considering all relevant possible treatment approaches, is determined to be the best treatment option.

Exclusions:

Laser interstitial thermal therapy for epilepsy radiation necrosis, recurrent glioblastoma and relapsed brain metastases that doesn’t meet the above criteria.

Laser interstitial thermal therapy is considered experimental for all other neurological conditions.

0421T, C2596

Basic benefit and medical policy

Aquablation of the prostate

Aquablation (transurethral waterjet ablation) of the prostate is considered established as an alternative to open prostatectomy or transurethral resection of the prostate for the treatment of benign prostatic hyperplasia.

The inclusionary criteria have been updated, effective May 1, 2024. Guidelines are listed below.

Inclusions:

Aquablation (transurethral waterjet ablation) for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia, or BPH, is considered established once per lifetime when all of the following criteria are met:

• The individual has prostate volume of 30-150 cc by transrectal ultrasound, or TRUS, and persistent moderate to severe symptoms despite maximal medical management including all of the following attributed to BPH:
• The individual has an International Prostate Symptom Score, or IPSS, of equal to or greater than 12.
• The individual has a peak urine flow rate (Qmax) less than or equal to 15mL/sec on a voided volume that is greater than 125 cc.
• The individual has had a failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride).

Exclusions:

The individual has none of the following:

• Severe obesity (BMI ≥ 42kg/m2)
• Known or suspected prostate cancer or a prostate specific antigen (PSA) >10 ng/mL unless there has been a negative prostate biopsy within the last six months
• Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum
• Damaged external urinary sphincter
• Treatment for chronic prostatitis
• Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture
• Active urinary tract or systemic infection
• Known allergy to device materials
• Inability to safely stop anticoagulants or antiplatelet agents preoperatively

64566, 97014, 97032, 0587T, 0588T, 0589T, 0590T

Experimental
64999, 0816T, 0817T, 0818T, 0819T

Basic benefit and medical policy

Percutaneous and implantable tibial nerve stimulation

The safety and effectiveness of percutaneous posterior tibial nerve stimulation, or TNS, for non-neurogenic urinary dysfunction have been established when criteria are met. It may be considered a useful therapeutic option when indicated.

Implantable TNS devices (e.g., eCoin, Revi) are considered experimental. Evidence is insufficient and hasn’t been shown to improve clinical health outcomes.

The Medical Policy Statement and inclusionary and exclusionary criteria have been updated, effective May 1, 2024. Guidelines are listed below.

Inclusions:

Initial 12-week course of percutaneous tibial nerve stimulation, or PTNS, for non-neurogenic urinary dysfunction including overactive bladder when the following are met:

• Both of the following have been attempted and have failed to yield adequate relief:
• Behavioral therapy (i.e., biofeedback, fluid management, pelvic floor exercises) following an appropriate duration of eight to 12 weeks of treatment.
• Pharmacologic therapy (i.e., anti-cholinergic drugs or a combination of an anti-cholinergic and a tricyclic anti-depressant) following four to eight weeks of treatment.

Maintenance^a therapy at a frequency of one per month, following a 12-week initial course of percutaneous tibial nerve stimulation up to a total of two years. The two-year time period begins with the induction of the initial course. 

^aFor continuation of treatment, evidence of improvement of symptoms (e.g., urinary frequency, nocturia or urinary urgency) should be obtained within the initial course of the PTNS treatment.

Exclusions:

• Percutaneous tibial nerve stimulation for all other indications, including but not limited to:
• Neurogenic bladder dysfunction
• Fecal incontinence
• Stress incontinence
• PTNS treatment beyond two years
• Implantable tibial nerve stimulation devices for all indications, including individuals with non-neurogenic urinary dysfunction (e.g., overactive bladder).

• Subcutaneous peripheral neurostimulator system (e.g., eCoin)
• Subfascial peripheral neurostimulator system (e.g., Revi).

S2095, Q3001, 37243, 79445

Basic benefit and medical policy

Radioembolization for liver tumors

The safety and effectiveness of radioembolization for primary and metastatic tumors of the liver are established. It may be considered a useful therapeutic option when indicated. Inclusionary and exclusionary criteria have been updated, effective May 1, 2024.    

Inclusions:

Radioembolization, referred to as selective internal radiation therapy, or SIRT, using radioactive Yttrium-90 (90Y) microspheres, is considered medically necessary when all the following criteria are met:

• Unresectable or medically inoperable primary or metastatic liver malignancies from any of the following:
• Unresectable liver only or liver dominant metastases from neuroendocrine tumors (e.g., carcinoids, pancreatic islet cell tumors, endocrine tumors).
• Unresectable primary hepatocellular carcinoma, or HCC, as a bridge to liver transplantation.
• Unresectable metastatic liver tumors from primary colorectal cancer.
• Treatment of unresectable liver metastases from breast carcinoma, ocular melanoma, cutaneous melanoma, or intrahepatic cholangiocarcinoma in the absence of available systemic or liver-directed treatment options to relieve symptoms and/or possibly extend life expectancy.
• Treatment of other radiosensitive tumors metastatic to the liver with liver-limited or liver-dominant disease for symptom palliation or prolongation of survival.
• The tumor burden should be liver dominant, not necessarily exclusive to the liver.
• Life expectancy should be at least three months.
• Radioactive Yttrium-90 (90Y) microspheres treatment is allowed only in the outpatient setting unless the documentation supports the medical necessity of inpatient treatment.

Repeat radioembolization is considered medically necessary for new or progressive primary or metastatic liver cancers when all the following criteria are met:

• The individual has had a previous satisfactory response to an initial radioembolization treatment as evidenced on results of a CT scan or PET/CT scan performed three months following the previous procedure. Response should be graded according to the revised Response Evaluation Criteria in Solid Tumors, or RECIST, guideline.
• The disease still must be liver dominant.
• Life expectancy of at least three months
• There are no other effective systemic or liver-directed treatment options.
• An individual has compensated liver function tests, or LFTs.
• Estimated lung dose and combined lung dose from previous embolizations are within acceptable dose volume constraints. Exclude an individual with lung shunting in which the lung radiation dose is greater than 25 to 30 Gy per treatment or greater than 50 Gy cumulatively for all treatments.
• Treatment should be given to a targeted tumor volume.

Exclusions:

• Used to treat previously untreated, or unresectable hepatic metastases from colorectal carcinoma.
• Repeat whole liver irradiation is considered experimental and won’t be certified.
• A third radioembolization treatment is considered not medically necessary.
• For all other hepatic metastases not described above.
• For all other indications not described above.

Yttrium-90 is contraindicated for patients who have:

• Had previous external beam radiation therapy of the liver
• Bleeding diathesis not correctable using standard medical means
• Severe pulmonary insufficiency
• Treatment that would result in greater than 25 to 30 Gy dose to the lung in one session or 50 Gy cumulative as assessed by Technetium MAA scan
• Pre-assessment angiogram that demonstrates vascular anatomy abnormalities that would result in significant reflux of hepatic arterial blood to the stomach, pancreas or bowel
• Disseminated and significant extrahepatic malignant disease
• History of treatment with capecitabine within two previous months, or who will be treated with capecitabine at any time following treatment with SIR-Spheres^®
• Portal vein thrombosis (relative)

Radioembolization isn’t recommended in pregnant women, nursing mothers or children.

C9399 J3490 J3590 J9999

Basic benefit and medical policy

Amtagvi™ (lifileucel)

Amtagvi (lifileucel) is considered established effective Feb. 16, 2024. 

Amtagvi is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate, or ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trials.
 
Dosage and administration:

For autologous use only. For intravenous use only.
Verify the patient's identity prior to infusion.

• Administer Amtagvi in an inpatient hospital setting with an intensive care facility. 
• The Amtagvi dose is between 7.5 x 10⁹ and 72 x 10⁹ viable cells.
• Administer a lymphodepleting regimen before infusion of Amtagvi.
• Don’t use a leukocyte depleting filter with Amtagvi.
• Premedicate the patient with acetaminophen, or equivalent, and diphenhydramine, or another H1-antihistamine.
• Avoid prophylactic use of systemic corticosteroids.
• Administer the entire dose of Amtagvi.
• Administer IL-2 (aldesleukin) after infusion of Amtagvi.

Dosage forms and strengths:

• Amtagvi is a cell suspension for intravenous infusion
• A single dose of Amtagvi contains 7.5 x 10⁹ to 72 x 10⁹ viable cells suspended in 1 to 4 patient-specific infusion bag or bags

This drug isn’t a benefit for URMBT.

J3490, J3590

Basic benefit and medical policy

Cosentyx^® (secukinumab)

Cosentyx (secukinumab) is considered established
when criteria are met, effective Oct. 6, 2023.

Cosentyx is a human interleukin-17A antagonist
indicated for the treatment of:

• Active psoriatic arthritis, or PsA, in patients 2 years of age and older
• Adults with active ankylosing spondylitis, or AS
• Adults with active non-radiographic axial spondyloarthritis, or nr-axSpA, with objective signs of inflammation

  Dosage and administration:

• Prior to Cosentyx initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis.
• Administration of intravenous formulation: Cosentyx for intravenous use must be diluted prior to administration.

• Administer as an intravenous infusion after dilution over a period of 30 minutes.

Psoriatic arthritis  ̶  Adult patients
Intravenous dosage:

• The recommended intravenous dosages are:
• With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every four weeks thereafter (maximum maintenance dose 300 mg per infusion).
• Without a loading dosage: 1.75 mg/kg every four weeks (maximum maintenance dose 300 mg per infusion).

Ankylosing spondylitis:

Intravenous dosage:

• The recommended intravenous dosages are:
• With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every four weeks thereafter (maximum maintenance dose 300 mg per infusion).
• Without a loading dosage: 1.75 mg/kg every four weeks (maximum maintenance dose 300 mg per infusion).

Non-radiographic axial spondyloarthritis:

Intravenous dosage:

• The recommended intravenous dosages are:
• With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every four weeks thereafter (maximum maintenance dose 300 mg per infusion).
• Without a loading dosage: 1.75 mg/kg every four weeks (maximum maintenance dose 300 mg per infusion).

Dosage forms and strengths:

Intravenous infusion:

• Injection: 125 mg/5 mL solution in a single-dose vial.